Family Based Contingency Management for Adolescent Alcohol Abuse

• ClinicalTrials.gov Identifier: NCT00595478
• Recruitment Status: Completed
• First Posted: January 16, 2008
• Results First Posted: March 29, 2018
• Last Update Posted: March 29, 2018
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Catherine Stanger, Dartmouth-Hitchcock Medical Center

Study Description

Brief Summary:

The goal is to adapt the family-based CM treatment to target primary adolescent alcohol abuse and dependence.

Specific Aim 1 is to provide a preliminary demonstration of the efficacy of a family-based CM intervention to treat adolescent alcohol abuse and dependence. CM components include:

1. an incentive program to enhance the adolescent's engagement in the treatment process and engender alcohol abstinence by providing positive reinforcement for documented abstinence via breathalyzers administered by parents regularly at home, self and parent report, and clinic-based urine drug testing; and
2. a parent management training program to enhance and maintain the positive effects of the incentive program by teaching parents how to effectively use contingency management in the home environment to motivate their adolescent to achieve abstinence and improve their behavior in other domains.

A randomized trial will determine whether the CM intervention enhances outcomes when added to a standard individual cognitive behavioral therapy (CBT).

Specific Aim 2 is to determine whether and how treatment interventions modify parental and adolescent risk and protective factors using observational and laboratory measures (parenting practices, family functioning, risk taking, delay discounting, and child and parent psychopathology) and to determine whether these factors are associated with outcomes over time.

Specific Aim 3 is to test gene x environment (treatment) interactions in adolescent substance abuse. Findings will extend the scientific evidence for CM and support the ability of parents to implement CM at home. Findings that support the CM model's efficacy will make a significant contribution to research on the treatment of adolescent alcohol abuse, which has lagged behind research on adult substance abuse and on adolescent illicit drug use.

Condition or disease	Intervention/treatment	Phase
Alcohol Abuse	Behavioral: Motivational Enhancement Therapy (MET)/CBT+CM; Behavioral: Motivational Enhancement Therapy (MET)/CBT	Not Applicable

Detailed Description:

Approximately 1.5 million youth ages 12-17 (representing 6.1% of all youth in that age range) are in need of treatment for alcohol abuse, yet only 7.2% of those in need of treatment received it. Importantly, most youth (90.5%) who were classified as needing treatment based on their self report of Adolescent Alcohol Study Plan; v.2; 3/30/12Page 2 of 35 symptoms, perceived no need for treatment. Thus, there is a need to develop treatments that target populations of alcohol abusing youth who are not highly motivated to change their substance use. New outpatient family based and contingency management interventions for adolescent marijuana abuse have been developed, yet none of these interventions has specifically targeted adolescent alcohol use. It is important to target primary alcohol abuse and dependence in adolescence as approximately 20% of treatment-seeking youth report primary problems with alcohol. The primary aim of this proposal is to adapt our family-based contingency-management treatment to target adolescent alcohol abuse and dependence. This project will develop, manualize, and pilot a contingency management intervention that includes two components. First, an incentive program will enhance the adolescent's engagement in the treatment process and engender alcohol abstinence by providing positive reinforcement for documented abstinence via breathalyzers administered by parents regularly at home, self and parent report, and clinic based urine drug testing. Second, a parent management training program will enhance and maintain the positive effects of the incentive program by teaching parents how to effectively use contingency management in the home environment to motivate their adolescent to achieve abstinence and improve their behavior in other domains.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Family Based Contingency Management for Adolescent Alcohol Abuse
• Study Start Date: August 2007
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Motivational Enhancement Therapy (MET)/CBT+CM/BPT	Behavioral: Motivational Enhancement Therapy (MET)/CBT+CM; Behavioral Treatment
Active Comparator: 2; Motivational Enhancement Therapy (MET)/CBT	Behavioral: Motivational Enhancement Therapy (MET)/CBT; Behavioral Treatment

Outcome Measures

Primary Outcome Measures :

1. Alcohol Abstinence [ Time Frame: Weekly up to 14 weeks ]
   Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)

Secondary Outcome Measures :

1. Days of Alcohol Use During 36-week Follow-up Period [ Time Frame: Monthly up to 9 months (36 weeks) ]
   Percentage of days alcohol used during the 36-week follow-up period after treatment ended measured via timeline follow-back.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 12-18 years old (if 18, must attend high school and live at home)
• Report using alcohol during the previous 30 days
• Have a parent/guardian who can participate
• Meet DSM criteria for either Alcohol Abuse or Dependence
• Youth who meet DSM criteria for Alcohol Dependence may also meet criteria for Marijuana Abuse or Dependence and other Drug Abuse
• Youth who meet DSM criteria for Alcohol Abuse, may also meet criteria for Marijuana or other Drug Abuse
• Live within a 30-minute drive of the clinic

Exclusion Criteria:

• Meet DSM criteria for Drug Dependence (other than Marijuana Dependence)
• Meet DSM criteria for Alcohol Abuse with Marijuana Dependence. Use of other drugs will not be excluded
• Participants will also be excluded if they exhibit an active psychosis
• Have a severe medical or psychiatric illness that will limit participation
• Are pregnant or breast-feeding

Contacts and Locations

Locations

United States, New Hampshire

Geisel School of Medicine at Dartmouth

Lebanon, New Hampshire, United States, 03766

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Catherine Stanger, Ph.D.; Dartmouth College

More Information

Publications of Results:

Stanger C, Scherer EA, Babbin SF, Ryan SR, Budney AJ. Abstinence based incentives plus parent training for adolescent alcohol and other substance misuse. Psychol Addict Behav. 2017 Jun;31(4):385-392. doi: 10.1037/adb0000279. Epub 2017 Apr 17.

• Responsible Party: Catherine Stanger, Associate Professor, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT00595478
• Other Study ID Numbers: 85846; 1R01AA016917-01 ( U.S. NIH Grant/Contract ); 1R01AA016917-02 ( U.S. NIH Grant/Contract ); 1R01AA016917-03 ( U.S. NIH Grant/Contract )
• First Posted: January 16, 2008
• Results First Posted: March 29, 2018
• Last Update Posted: March 29, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders